NCT06792981 Evaluation of a Digital School-Based Intervention for the Primary Prevention of Eating Disorders in Pre-Adolescents (PRETA Program)
| NCT ID | NCT06792981 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Servicio Canario de Salud |
| Condition | Eating Disorders in Adolescence |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,068 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,068 participants in total. It began in 2025-03-10 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Eating Disorders (ED) are mental health conditions, characterized by pathological behaviors toward food intake or a persistent obsession with weight control. EDs have a high prevalence among pre-adolescents in developed countries and pose a significant economic burden. Preventive interventions targeting at-risk populations for ED have proven effective. The use of Information and Communication Technologies (ICTs) facilitates access to larger population groups while also reducing costs. Objectives: * Develop and validate a universally applied intervention (PRETA), mediated by ICTs, to reduce eating-disorder risk and modifiable risk factors, through cultural adaptation and adjustment of the POtsdam Prevention at Schools (POPS) Program to preadolescents. * Assess the efficacy of the PRETA Program through a randomized controlled trial (RCT). * Evaluate the efficiency of the PRETA Program from a social perspective. Methodology The PRETA Program uses 9 online sessions with interactive activities for pre- adolescents, plus education for their families and teachers. Its content includes addressing key factors in the development of ED, such as eating habits, beauty standards, and media literacy, as well as activities aimed at strengthening psychological dimensions (self-esteem, emotional regulation, problem-solving, psychological flexibility, and resilience) and social skills, including communication styles and distinguishing between jokes and bullying. The study involves schools being randomly assigned to either the PRETA Program or regular health activities. The effect of the intervention will be evaluated 3 months after its start.
Eligibility Criteria
Inclusion Criteria: * Enrolled in the fifth or sixth year of primary education. * Informed consent provided by the student's legal guardians and responsible teacher to participate. Exclusion Criteria: * Significant comprehension difficulties that limit adequate participation in the program and questionnaires.
Contact & Investigator
Yolanda Ramallo-Fariña, PhD in Biomedical Sciences
PRINCIPAL INVESTIGATOR
Servicio de Evaluación del Servicio Canario de la Salud
Frequently Asked Questions
Who can join the NCT06792981 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 13 Years, studying Eating Disorders in Adolescence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06792981 currently recruiting?
Yes, NCT06792981 is actively recruiting participants. Contact the research team at yolanda.ramallofarina@sescs.es for enrollment information.
Where is the NCT06792981 trial being conducted?
This trial is being conducted at Santa Cruz de Tenerife, Spain.
Who is sponsoring the NCT06792981 clinical trial?
NCT06792981 is sponsored by Servicio Canario de Salud. The principal investigator is Yolanda Ramallo-Fariña, PhD in Biomedical Sciences at Servicio de Evaluación del Servicio Canario de la Salud. The trial plans to enroll 1,068 participants.